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Metabolic Effects of Switching Kaletra to Boosted Reyataz

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ClinicalTrials.gov Identifier: NCT00413153
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : March 3, 2010
Last Update Posted : March 9, 2010
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Massachusetts General Hospital

Study Description
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Brief Summary:
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: atazanavir/ritonavir Drug: lopinavir/ritonavir Not Applicable

Detailed Description:
The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months. Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG) imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Switching Kaletra to Boosted Reyataz
Study Start Date : May 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
 Drug: atazanavir/ritonavir
atazanavir 300mg + ritonavir 100mg once daily
Other Name: Boosted Reyataz
Active Comparator: 2
Kaletra (pre-study dose)
 Drug: lopinavir/ritonavir
patient remains on their pre-study dose of lopinavir/ritonavir
Other Name: Kaletra


Outcome Measures
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Primary Outcome Measures :
  1. Glucose Trafficking [ Time Frame: 6 months ]
    6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or "trafficked to") muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity.


Secondary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: 6 months ]
    6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.

  2. Fasting Glucose [ Time Frame: 6 months ]
    6 month mean and standard deviation for fasting glucose.

  3. Lipid Metabolism - Serum Triglyceride [ Time Frame: 6 months ]
    6 month mean and standard deviation for serum triglyceride.

  4. Body Composition - Visceral Adipose Tissue [ Time Frame: 6 months ]
    6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).

  5. Immune Parameters -- CD4 Count [ Time Frame: 6 months ]
    6 month mean and standard deviation for CD4+ count.

  6. Liver Enzymes -- Aspartate Aminotransferase (AST) [ Time Frame: 6 months ]
    6 month mean and standard deviation for AST.

  7. Liver Enzymes -- Alanine Aminotransferase (ALT) [ Time Frame: 6 months ]
    6 month mean and standard deviation for ALT.

  8. Total Bilirubin [ Time Frame: 6 months ]
    6 month mean and standard deviation for total bilirubin.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously diagnosed HIV infection
  2. Age between 18-65 years
  3. Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
  4. CD4 count > 400 cell/mm3
  5. Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin >= 15 mIU/ml), hypercholesteremia (fasting total cholesterol >= 200 mg/dL), hypertriglyceridemia (fasting triglycerides >= 150 mg/dL), or treatment with a lipid lowering medication.

Exclusion Criteria:

  1. Hemoglobin < 11.0 g/dL
  2. History of Diabetes Mellitus
  3. Currently on medication for Diabetes
  4. Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
  5. Current substance abuse, including alcohol, cocaine and/or heroin
  6. Any contraindication to ATV/r or known allergy to ATV
  7. Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam
  8. New or serious opportunistic infection in the past 3 months
  9. Pregnancy
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413153


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Bristol-Myers Squibb
Investigators
Principal Investigator: Steven K Grinspoon, MD MGH
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00413153     History of Changes
Other Study ID Numbers: 2005-P-002239
First Posted: December 19, 2006    Key Record Dates
Results First Posted: March 3, 2010
Last Update Posted: March 9, 2010
Last Verified: March 2010

Keywords provided by Massachusetts General Hospital:
HIV
Kaletra
Reyataz
Insulin sensitivity
 Lipids
Body Composition
Receiving Kaletra
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
 Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors